Patients' attitudes to participation in clinical trials.

Bevan, E. G.; Chee, LC; McGhee, SM; McInnes, GT

doi:10.1111/j.1365-2125.1993.tb05687.x

Cited by 91 publications

(115 citation statements)

References 6 publications

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“…Other authors, who have investigated the willingness of patients in participating in hypothetical [10][11][12][13] or real trials, 14,15 have reported similar rates, ranging from 50 to 66%. However, only 74% (71/96) of the interested patients in our investigation actually consented to participate.…”

Section: Discussionmentioning

confidence: 82%

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Study participation rate of patients with acute spinal cord injury early during rehabilitation

et al. 2015

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Study design: Retrospective observational study. Objectives: To investigate the study participation rate of patients with acute spinal cord injury (SCI) early during rehabilitation after conveying preliminary study information. Setting: Single SCI rehabilitation center in Switzerland. Methods: Newly admitted acute SCI patients receive a flyer to inform them concerning the purpose of clinical research, patient rights and active studies. Upon patient request, detailed study information is given. The rate of patients asking for detailed information (study interest) and the rate of study participation was evaluated from May 2013 to October 2014. Furthermore, the number of patients not withdrawing consent to the utilization of coded health-related data was determined. Results: The flyer was given to 144 of the 183 patients admitted during the observation period. A total of 96 patients (67%) were interested in receiving detailed information, and 71 patients (49%) finally participated in at least one study. The vast majority of patients (that is, 91%) did not withdraw consent for retrospective data analysis. An age over 60 years had a significantly (P ⩽ 0.023) negative effect on study interest and participation, and the consent rate to retrospective data analysis was significantly (Po0.04) lower in patients older than 75 years. Study interest and participation were reduced more than 5 and 14-fold, respectively, in patients older than 60 years. Conclusions: The relatively low (approximately 50%) study participation rates of acute SCI patients should be considered when planning clinical trials. The recruitment of patients older than 60 years may be reduced substantially.

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Section: Discussionmentioning

confidence: 82%

“…Improvement of one's own treatment or altruistic motivation are common considerations for study participation. 10 In contrast, invasive procedures and the fear of side-effects reduce study participation rates. 10 Other common reasons for declining participation are insufficient time resources and poor physical or mental condition.…”

Section: Discussionmentioning

confidence: 99%

Study participation rate of patients with acute spinal cord injury early during rehabilitation

et al. 2015

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“…Reasons for refusals to participate appear to vary according to the type of trial and the severity of treatment, 487 with key factors including inconvenience, difficulties with transport, too many clinic visits and time taken, as well as a distrust of medicine or the hospital and worries about side effects. 488,489 Much of the literature examining trial participation has identified altruism, trust in recruiting clinicians and an expectation of personal benefit as the main motivations for participation in trials. 490,491 However, altruism may be overstated as a motivation for participants, and a small but increasing number of studies using qualitative methods to examine the perspectives of clinical trial participants [484][485][486] have concluded that patients participate in a clinical trial because they believe that they are receiving personalised care.…”

Section: Patient and Public Involvementmentioning

confidence: 99%

Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

Webster

Groskreutz

Grinbergs-Saull

et al. 2017

Health Technol Assess

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Background: There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. Objectives: To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). Data sources: We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches. Review methods: The project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. Results: We included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. Limitations: Most of the trials inclu...

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“…In contrast, when attitudes of patients to participation in therapeutic trials are assessed, altruistic motives appear to be relevant [2]. However, the economic gain might not fully explain why only a subgroup of subjects decides to take part in clinical trials.…”

Section: Introductionmentioning

confidence: 94%

Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

Farré

Lamas

Camı́

1995

Brit J Clinical Pharma

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compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P < 0.0001), boredom susceptibility (3.9 vs 2.8, P = 0.0073), total sensation seeking trait (24.3 vs 19.0, P < 0.0001), extraversion (15.1 vs 13.3, P = 0.0490), and psychoticism (4.4 vs 3.5, P = 0.0086). When healthy volunteers were compared with general norm data similar statistically significant differences were found in all these scales, except for boredom susceptibility and psychoticism. 4 The personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data.

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Patients' attitudes to participation in clinical trials.

Cited by 91 publications

References 6 publications

Study participation rate of patients with acute spinal cord injury early during rehabilitation

Study participation rate of patients with acute spinal cord injury early during rehabilitation

Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

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